A Study of Assessment on Safety and Effectiveness of BWI Pulsed Field Ablation With OMNYPULSE Catheter for the Treatment of Paroxysmal Atrial Fibrillation (PAF) (OMNY-AF)

Assessment of Safety and Effectiveness in Treatment Management of Paroxysmal Atrial Fibrillation With the BWI Pulsed Field Ablation System With OMNYPULSE™ Catheter

The purpose of this study is to demonstrate the safety and 12-month effectiveness of the BWI OMNYPULSE™ pulsed field ablation (PFA) platform for pulmonary vein isolation (PVI) in the treatment of participants with symptomatic paroxysmal atrial fibrillation (PAF), an irregular heart rate that causes abnormal blood flow.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: OMNYPULSE™ Catheter with the TRUPULSE Generator

• Study Type: Interventional
• Enrollment (Estimated): 440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 949-789-3919; Email: rshar120@its.jnj.com

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Recruiting
    • Royal Adelaide Hospital
  • Garran, Australia, 2605
    • Withdrawn
    • Canberra Heart Rhythm
  • Parkville, Australia, 03052
    • Recruiting
    • Royal Melbourne Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Recruiting
      • Phoenix Cardiovascular Research Group
  • California
    • Burlingame, California, United States, 94010
      • Recruiting
      • Mills Peninsula Health Services
    • La Jolla, California, United States, 92037
      • Withdrawn
      • Scripps Clinic/Prebys Cardiovascular Institute
    • Larkspur, California, United States, 94939
      • Recruiting
      • Cardiovascular Associates of Marin
    • Loma Linda, California, United States, 92354
      • Withdrawn
      • Loma Linda Medical Center
    • Newport Beach, California, United States, 92663
      • Recruiting
      • Hoag Memorial Hospital
    • San Diego, California, United States, 92123
      • Recruiting
      • San Diego Cardiac Center
    • San Francisco, California, United States, 94109
      • Withdrawn
      • California Pacific Medical Center- Sutter Health
    • Santa Monica, California, United States, 90404
      • Withdrawn
      • Providence Saint John s Health Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Recruiting
      • Hartford Hospital
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Recruiting
      • Ascension St. Vincent's
    • Jacksonville, Florida, United States, 32207
      • Recruiting
      • Baptist Health Research Institute
    • Miami, Florida, United States, 33133
      • Recruiting
      • HCA Florida Mercy Hospital
    • Naples, Florida, United States, 34102
      • Recruiting
      • NCH Healthcare
    • Orlando, Florida, United States, 32803
      • Recruiting
      • Advent Health Orlando
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Northside Hospital
    • Atlanta, Georgia, United States, 30342
      • Recruiting
      • Emory Saint Joseph's Hospital
    • Atlanta, Georgia, United States, 30309
      • Recruiting
      • Piedmont Healthcare
    • Savannah, Georgia, United States, 31404
      • Recruiting
      • Memorial Health University Medical Center
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Recruiting
      • NorthShore University Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Recruiting
      • Beaumont Health Systems
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • Recruiting
      • Minneapolis Heart Institute
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Recruiting
      • Morristown Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Recruiting
      • New Mexico Heart Institute
  • New York
    • New York, New York, United States, 10075
      • Recruiting
      • Lenox Hill Hospital
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai School of Medicine
    • New York, New York, United States, 10065
      • Recruiting
      • New York Presbyterian - Weill Cornell Medical Ctr
    • Roslyn, New York, United States, 11576
      • Recruiting
      • St Francis Hospital
    • The Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
  • North Carolina
    • Raleigh, North Carolina, United States, 27610
      • Recruiting
      • WakeMed Heart & Vascular
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania Health System
    • York, Pennsylvania, United States, 17403
      • Recruiting
      • York Hospital
  • Texas
    • Austin, Texas, United States, 78705
      • Recruiting
      • Texas Cardiac Arrhythmia Research Foundation
    • Houston, Texas, United States, 77030
      • Recruiting
      • Texas Heart Institute
  • Utah
    • Murray, Utah, United States, 84107
      • Recruiting
      • Intermountain Medical Center
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Recruiting
      • Inova Fairfax Medical Campus- Inova Heart and Vascular Institute
    • Norfolk, Virginia, United States, 23507
      • Recruiting
      • Sentara Norfolk General Hospital
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with symptomatic paroxysmal AF with:

  1. At least two symptomatic AF episodes within last six months from enrollment
  2. At least one electrocardiographically documented AF episode within twelve months prior to enrollment
• Failed at least one Class I or Class III antiarrhythmic drug
• Willing and capable to provide consent
• Able and willing to comply with all pre-, post- and follow-up testing and requirements

Exclusion Criteria:

• Previously diagnosed with persistent AF (greater than [>] 7 days in duration)
• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Previous surgical or catheter ablation for AF
• Patients known to require ablation outside the PV ostia and outside the CTI region.
• Documented severe dilatation of the left atrium (LAD>50 mm) antero-posterior diameter on imaging within 6 months prior to enrollment
• Documented left atrium (LA) thrombus by imaging within 48 hours of the procedure
• Documented severely compromised left ventricular ejection fraction (LVEF <40%) by imaging within 6 months prior to enrollment
• Uncontrolled heart failure or New York Heart Association (NYHA) Class III or IV
• History of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran)
• Documented thromboembolic event (including transient ischemic attack or TIA) within the past 6 months
• Previous Percutaneous Coronary Intervention (PCI)/ myocardial infarction [MI] within the past 2 months
• Coronary Artery Bypass Grafting (CABG) surgery within the past 6 months
• Valvular cardiac surgical/percutaneous procedure
• Unstable angina within 6 months
• Anticipated cardiac transplantation, cardiac surgery, or other major surgery within the next 12 months
• Significant pulmonary disease or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
• Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
• Prior diagnosis of pulmonary vein stenosis
• Pre-existing hemi diaphragmatic paralysis
• Acute illness, active systemic infection, or sepsis
• Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation
• Severe mitral regurgitation
• Presence of an implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device (other than coronary stents) that may interfere with the PF energy field)
• Presence of a condition that precludes vascular access
• Current enrollment in an investigational study evaluating another device or drug
• Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child-bearing age and plan on becoming pregnant during the course of the clinical investigation
• Life expectancy less than 12 months
• Presenting contra-indications for the devices used in the study, as indicated in the respective Instructions for Use (IFU)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulsed Field (PF) Ablation System; Participants with PAF will undergo pulsed field ablation procedure with the OMNYPULSE™ catheter in combination with TRUPULSE™ generator for PVI and to deliver pulsed field (PF) energy for treatment of atrial fibrillation. Study participants will be followed for 12 months after the study index procedure.	Device: OMNYPULSE™ Catheter with the TRUPULSE Generator; OMNYPULSE™ Catheter and TRUPULSE™ Generator will be used for PF ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Primary Adverse Events (PAEs)	Number of participants with PAEs (within 7 days following the ablation procedure unless otherwise indicated) will be reported. PAEs will include the following adverse events: esophageal perforating complications (atrio-esophageal fistula, esophago-pericardial fistula), phrenic nerve paralysis (permanent), cardiac tamponade/perforation, pulmonary vein stenosis (PVS), device or procedure related death, stroke/cerebrovascular accident (CVA), major vascular access complication/bleeding, thromboembolism, myocardial infarction, transient ischemic attack (TIA), pericarditis, heart block, pulmonary edema (respiratory insufficiency) and vagal nerve injury/gastroparesis.	7 days post-procedure
Number of Participants Reporting Freedom from Documented (Symptomatic and Asymptomatic) Atrial Tachyarrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT] or Atrial Flutter [AFL] of Unknown Origin) Episodes	Number of participants reporting freedom from documented (symptomatic and asymptomatic) atrial tachyarrhythmia (AF, AT, or AFL of unknown origin) episodes of >= 30 seconds based on sponsor provided transtelephonic monitoring (TTM) or holter device or continuous on standard 12-lead electrocardiogram (ECG) data during the effectiveness evaluation period will be reported.	Day 91 to Day 365 post-procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score	The AFEQT uses a questionnaire to evaluate symptoms, daily activities and treatment concerns participants have related to atrial fibrillation. An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" difficult to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). A positive change in score corresponds to improvement in AF symptoms.	Baseline, Month 12

Collaborators and Investigators

• Sponsor: Biosense Webster, Inc.
• Investigators: Study Director: Biosense Webster, Inc. Clinical Trial, Biosense Webster, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 7, 2024
• First Submitted That Met QC Criteria: June 7, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation
• Other Study ID Numbers: BWI202303 (Other Identifier: Biosense Webster, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson and Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes